A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of TJ101 in Patients With Advanced/Metastatic Solid Tumors

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorPhrontline Biopharma

About this trial

The goal of this clinical trial is to evaluate whether TJ101, an investigational antibody-drug conjugate (ADC), can safely and effectively treat patients with advanced solid tumors.

The main objectives of this study are :

* To Determine the maximum tolerated dose (MTD) and recommended dose for expansion (RDE) of TJ101 * to show preliminary antitumor activity in patients with advanced solid tumors

Participants will:

* Receive intravenous (IV) infusions of TJ101 at escalating dose levels (during dose escalation) or at the selected expansion dose. * Undergo regular tumor imaging to assess response. * Provide blood samples for pharmacokinetics (PK) and biomarker analysis. * Be monitored for side effects and overall tolerability.

This study is being conducted in adult patients with advanced or metastatic solid tumors who have exhausted standard treatment options

Eligibility criteria

Qualifiers

Histological and/or cytological diagnosis of advanced/metastatic solid tumors, who have failed standard treatment, or have no standard therapy.

Have at least one measurable lesion by RECIST v1.1 (Eisenhauer et al., 2009) for solid tumors.

Men or women ≥18 years old.

Eastern Cooperative Oncology Group (ECOG) performance status (Oken et al., 1982) of 0 to 1.

Disqualifiers

Has received treatment of topoisomerase 1 inhibitors (TOP1i), including topotecan, irinotecan, belotecan, and TOP1i-based antibody-drug conjugates (ADCs, eg, sacituzumab govitecan, trastuzumab deruxtecan, zalontamab brengitecan, sacituzumab tirumotecan etal);

Has known hypersensitivity to any component of TJ101 or has a history of severe hypersensitivity reactions to other monoclonal antibodies;

Has received mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration; oral fluorouracil-like drugs such as S-1, capecitabine, or palliative radiotherapy within 2 weeks prior to the first administration; Has received other chemotherapy, biological therapy, immunotherapy, major surgery, radical radiotherapy, targeted therapy (including small molecule inhibitor of tyrosine kinase) and other anti-tumor therapy within 5 half-lives or 28 days, whichever is shorter, prior to the first administration of TJ101; Has received anti-tumor herbal medicine within 14 days prior to first dose of TJ101;

Has received a strong or moderate CYP3A4 inhibitor within 3 half-lives;

Trial design

Treatments tested in this trial

  • TJ101

Treatment groups

200 Participants
are divided into 1 treatment group

Sponsors and collaborators